BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153621 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06891
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 10, 2011
    Report Date
    December 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A RED RASH ON THE IMPLANT POCKET APPROXIMATELY TWO WEEKS POST IMPLANT. UPON FURTHER EVALUATION OF THE POCKET AREA, IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND LEADS WERE CLEANED AND RE-IMPLANTED SUBPECTORAL. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT APPROXIMATELY EIGHT MONTHS LATER DUE TO INFECTION. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R N119| H177| 0158| 4479| 4542